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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016208
Receipt No. R000018807
Scientific Title A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus
Date of disclosure of the study information 2015/02/01
Last modified on 2017/05/16

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Basic information
Public title A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus
Acronym A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus
Scientific Title A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus
Scientific Title:Acronym A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus
Region
Japan

Condition
Condition Morbid obese patients with diabetes mellitus
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of Laparoscopic Sleeve Gastrectomy / Duodeno-Jejunal Bypass: LSG / DJB
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate safety
Confirm postoperative complications within 30 post operative days

To evaluate efficacy
HbA1c at 12months after surgery
Key secondary outcomes To evaluate safety
1, Confirm the presence or absence of malnutrition after the operation
at 12months after surgery

To evaluate efficacy
1, Effect on weight loss
2, Confirm medication status of diabetes drugs
at 12months after surgery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Opetarion
Laparoscopic sleeve gastrectomy/duodenojejunal bypass
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1, Age: 18-65 years of age
2, Gender: unquestioned
3, BMI: 32Kg/m2 or more
4, Less than 5 points in the m-ABCD score
5, including patients whose effects after laparoscopic sleeve-gastrectomy are not sufficient, satisfying above criteria 1-4
Key exclusion criteria 1, Patiens mental disorders are clearly involved in morbid obesity Background
2, Secondary obesity associated with endocrine disorders
3, Patients determined not to be expected the effect of weight loss surgery
4, Patients with severe renal dysfunction
5, Patients with severe liver failure
6, Pregnant women or women who may possibly be pregnant
7, Patients determined to be inappropriate as a test subject by investigators
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Naitoh
Organization Tohoku University Hospital
Division name Department of surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL 022-717-7205
Email naitot@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Tanaka
Organization Tohoku University Hospital
Division name Department of surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL 022-717-7205
Homepage URL
Email n-tanaka@surg1.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization own research funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 30 Day
Date trial data considered complete
2020 Year 04 Month 30 Day
Date analysis concluded
2020 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 13 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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